Recommendations for creating realistic medical device and healthcare product test environments
US regulators lay out recommendations for HFE information to include in medical device registration applications
Join the HFE experts at Emergo by UL as they discuss both tips to follow and pitfalls to avoid when writing medical device user interface requirements.
A use-related risk analysis (URRA) is an important cornerstone activity in your human factors engineering (HFE) process that is expected by regulators.
Electronic indications for use (IFUs) becoming more common for medical products and devices
Learn best practices for creating safer and more effective electronic instructions for medical devices, including eIFU design and regulatory requirements.
Emergo by UL’s cloud-based human factors engineering (HFE) platform, Optimal Product Usability Suite (OPUS), leverages training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.
Our human factors research and design experts help put safer, more competitive devices in the hands of patients and healtcare providers. See how we can help at every stage of your product development.
We provide human factors training and consulting to educate the medical device community about the benefits of human factors engineering to patients and healthcare professionals.
Emergo by UL's medical device usability testing and evaluation includes summative usability testing, formative usability testing, expert critiques, heuristic analyses, cognitive walkthroughs, and more.